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Shock, Septic clinical trials

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NCT ID: NCT05325957 Not yet recruiting - Septic Shock Clinical Trials

Effects of Norepinephrine and Volume Expansion in Capillary Refill Time in Septic Shock in Angers University Hospital

NOVECAR-A
Start date: May 2022
Phase:
Study type: Observational

the purpose of this study is to assess the effect of norepinephrine and fluid expansion on capillary refill time during septic shock.

NCT ID: NCT05315557 Not yet recruiting - Septic Shock Clinical Trials

Efficacy and Safety of Vasopressin Versus Terlipressin as a Second Vasopressor in Critically Ill Cirrhotics With Septic Shock- the VITEL-C Trial

Start date: April 5, 2022
Phase: N/A
Study type: Interventional

Sepsis is a life-threatening organ dysfunction caused by dysregulated host response. A Subset of sepsis is septic shock which has almost 4-6 times the mortality when compared to sepsis. Septic shock has underlying cellular and metabolic abnormalities in addition to circulatory dysfunction. The circulatory dysfunction in sepsis is in the form of severe vasodilatation with high cardiac index. Cirrhosis is a state of hyperdynamic circulation. The mortality of septic shock in these group of patients is still higher. At the onset of septic shock there is initially an increased secretion of Arginine vasopressin. However, this initial rise is short lasting, and the vasopressin levels come back to normal or low serum levels with continued hypotension. However, even normal levels are too low for the degree of hypotension in septic shock. This causes a relative deficiency of vasopressin in septic shock. The exact time when this fall happens is not known and it is likely to be variable. Vasopressin was therefore tried as an agent in septic shock. Terlipressin is a synthetic analogue of vasopressin. It has a greater selectivity for the V1 receptor. Terlipressin is also shown to be effective in septic shock in cirrhotics3. Other vasoactive agents are not preferred in cirrhotics - dopamine due to high risk of arrhythmias and dobutamine as baseline cardiac output of cirrhotics is high which further increases in sepsis and dobutamine would further add to it. However, it may be given in myocardial dysfunction. Noradrenaline is recommended as the first vasopressor to be started in general in septic shock population. No study has compared the effectiveness of vasopressin and Terlipressin when added to noradrenaline in patients with cirrhosis. Acute kidney injury is a very common complication of septic shock in cirrhotics.

NCT ID: NCT05310942 Active, not recruiting - Septic Shock Clinical Trials

Non Invasive Evaluation of Fluid Responsiveness in Septic Patient

Start date: December 17, 2021
Phase:
Study type: Observational

The study aims to evaluate the accuracy of fluid responsiveness assessment with non-invasive cardiometry compared to ultrasound guided inferior vena cava (IVC) collapsibility for management of critically ill septic patients with hemodynamic instability.

NCT ID: NCT05296590 Active, not recruiting - Sepsis Clinical Trials

Monocyte Distribution Width (MDW) in the General Population of Emergency Department Patients With and Without Bacteremia

Start date: July 1, 2021
Phase:
Study type: Observational

This project will evaluate the usefulness of Monocyte Distribution Width (MDW) for the diagnosis of blood culture positivity (BSI) in patients in the Emergency Department (ED) and reevaluate the usefulness of MDW in patients with BSI and sepsis. Consequently, if MDW indicate a high likelihood of bacteremia antibiotic management in patients with suspected bacterial infections will be changed and aid appropriate antibiotic administration.

NCT ID: NCT05289388 Not yet recruiting - Septic Shock Clinical Trials

a Novel Index for Tissue Perfusion in Predicting Outcome in Patients With Septic Shock

Start date: March 2022
Phase:
Study type: Observational

Septic shock is a life-threatening condition with mortality rate of up to -40%. Septic shock is catheterized by altered microcirculation that leads to tissue hypoperfusion and ultimately multi-organ dysfunction. Hence, maintenance of adequate tissue perfusion is the mainstay of resuscitation of patients with septic shock. Serum lactate is still considered the gold standard for evaluation of tissue perfusion. Thus, according to the latest definition, elevated serum lactate, as an indicator of tissue hypo-perfusion, is required for diagnosis of septic shock. However, lactate level change in response to resuscitation is slow even in survivors. Capillary refill time (CRT) is a simple method for assessing peripheral perfusion. Monitoring CRT was found to be a good tool for guiding resuscitation and delayed CRT showed good ability in predicting mortality in patients with septic shock. To the best of our knowledge, there is no previous report assessing the reliability of an index that include both serum lactate and CRT (lactate/CRT index) in predicting mortality in patients with septic shock. We hypothesize that the lactate/CRT index would have good accuracy in predicting mortality in patient with septic shock.

NCT ID: NCT05283317 Completed - Sepsis Clinical Trials

Effect of Mesenchymal Stromal Cells on Sepsis and Septic Shock

Start date: March 11, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

Methods:Ten patients were enrolled in the study. Adipose derived-MSCs infusions were given (1x 106/ kg, on 1st, 3rd, 5th, 7th and 9th days of therapy) together with Standard therapy. Before the MSCs applications, blood samples were collected for cytokine assessment (TNF-α, IFN-γ, IL-2, IL-4, IL-6, IL-10). The clinical and laboratory improvements were recorded and compared with control groups selected retrospectively.

NCT ID: NCT05283083 Completed - Sepsis Clinical Trials

Decatecholaminisation of Septic Shock With Dexmedetomidine and In-hospital Mortality

DECATSepsis
Start date: March 25, 2022
Phase: Phase 2
Study type: Interventional

The study aims to determine whether the infusion of DEX in septic shock can reduce in-hospital mortality, norepinephrine infusion, need and duration for mechanical ventilation, and acute kidney injury without significant adverse events.

NCT ID: NCT05271032 Completed - Septic Shock Clinical Trials

PiCCO ASSESSMENT IN PATIENTS WITH SEPTIC SHOCK

Start date: March 1, 2018
Phase:
Study type: Observational

Sepsis is the result of a complex pathological process which involves an intravascular inflammatory state, loss of vascular tone, endothelial injury, extravascular leakage, and often inefficient myocardial contractility. These affect the cardiovascular homeostasis as well as the regional perfusion and tissue oxygenation of patient. The importance of early cardiovascular support in septic patients is the reason why, for about fifteen years, the implementation of standardized resuscitation protocols has been emphasized. The Surviving Sepsis Campaign Guidelines (SSG) recommend an initial fluid resuscitation followed by use of a vasoactive agent such as norepinephrine for the treatment of patients with septic shock. To understand the impact of the hemodynamic support provided by the resuscitation strategy, the assessment of surrogate clinical parameters is pivotal. According to the current guidelines, the increase of mean arterial pressure (MAP) above 65 mmHg represents the threshold in defining patients as "stable". Although this strategy has been well established, its impact on the actual hemodynamic profile of the septic patient, remains a subject of ongoing controversy. In this scenario, the transpulmonary thermodilution technique (TPTD) allows invasive assessment of the patient hemodynamic profile in terms of fluid responsiveness, vasomotor status, or global cardiac efficiency. By using this technique, several studies highlighted a wide variability in the individual response of patients undergoing cardiovascular stabilization guided by SSG. This suggests that the implementation of a "customized" resuscitation protocol based TPTD derived parameters rather than resuscitation strategy guided by a fixed mathematic model, could be preferred. However, in daily clinical practice, the use of this advanced hemodynamic monitoring system in not routinely used, though it is often reserved in case of failure of the initial SSG-resuscitation protocol. The investigators supposed that, even if the initial resuscitative efforts were successful in achieving the SSG targets i.e. by restoring the MAP > 65 mmHg, this could still be inadequate in some patients. Accordingly, the investigators hereby will report the hemodynamic profile of patients with septic shock admitted in ICU.

NCT ID: NCT05270798 Completed - Septic Shock Clinical Trials

Thyroid Hormone Supplementation in Patients With Septic Shock

Start date: May 1, 2022
Phase: Phase 2
Study type: Interventional

The primary aim of the study would be to determine whether there is a difference in survival in the Intensive Care Unit between the group of patients with septic shock diagnosed with euthyroid sick syndrome who were treated with T3 hormone compared to the group of patients not treated with this hormone. Secondary objectives of the research would be: Compare the level of thyroid hormones between the examined groups and 1. laboratory indicators of septic shock (C-reactive protein-CRP, procalcitonin, leukocytes, acid-base status, lactates) 2. APACHE II, SOFA and SAPS II patient assessment scales, 3. inflammatory prognostic systems (ratio of CRP and albumin-modified Glasgow prognostic score-mGPS, ratio of neutrophils and lymphocytes - NLR, ratio of platelets and lymphocytes - PLR, and ratio of leukocytes and CRP, prognostic index - PI) 4. hemodynamic stability of patients (MAP, systolic and diastolic pressure) in the periods of admission T0, T3, T6, T12, T24 and every 24 hours for 4 days, 5. effect of vasoactive drugs, 6. the need for mechanical ventilation categorized as yes or no, in case - number of respirator days, 7. length of stay in the Intensive Care Unit, 8. treatment outcome categorized as 28 day survival.

NCT ID: NCT05257759 Recruiting - Septic Shock Clinical Trials

Use of Neurostimulation as a Tool for Reconditioning the Neuromuscular System of Patients Admitted to the ICU for Septic Shock

STIMUREA
Start date: March 25, 2022
Phase: N/A
Study type: Interventional

Patients hospitalized in the ICU are likely to develop sarcopenia due to a progressive and generalized decrease in muscle mass that is responsible for generalized muscle weakness known as resuscitation neuromyopathy. This neuromyopathy is known make weaning from mechanical ventilation more difficult, which prolongs the hospitalization of patients in the ICU and in hospital. The factors identified as being partly responsible for this neuromyopathy are: immobilization, undernutrition, prolonged duration of mechanical ventilation, inflammation (notably secondary to sepsis), and multivisceral failure. These factors are essentially found in patients in septic shock, which represents about 20% of patients admitted to the ICU, with a mortality rate close to 50%. If the management of septic shock is now well codified (i.e. vascular filling, antibiotics and/or treatment of the infectious focus by surgery +/- organ replacement therapy) as well as the early rehabilitation of ICU patients, no treatments has yet been proven to be effective in limiting the appearance of resuscitation neuromyopathy. For the last ten years, research using electrostimulation (ES) to improve muscle contraction seems to give encouraging results, both for length of hospital stay and the duration of mechanical ventilation, notably through the preservation or a significant increase in muscle strength. On the other hand, other studies did not show a significant effect on muscle strength. These conflicting results are partly related to the heterogeneity of the populations included in the studies and to the different ES approaches used to assess and recondition motor function. In the present STIMUREA study, an original approach is proposed based on experimental research work carried out for many years within U1093 (Pr Charalambos Papaxanthis) which focuses on ES, not of the muscle surface as in most studies carried out in the ICU, but an approach based on ES of the motor nerve. Indeed, the intensity of ES used in previous studies was based on a maximum tolerated intensity leading to a direct recruitment of the most fatiguable motor units (via the activation of motor axons) but leading, in fine, to a decrease in muscle strength. The U1093 research team and previous studies have shown that protocols using high stimulation frequencies (100Hz) associated with pulse widths of 1ms and delivered at low intensities (5-10% of the maximum voluntary contraction, MVC) at the level of the motor nerve, could increase the force developed during the contraction, while decreasing the discomfort induced by the high intensities. This increase in force would be due to the indirect activation of motor neurons via large diameter sensory afferents, thus leading to a recruitment of motor units similar to that observed during voluntary contractions. In a very recent study conducted in our laboratory (INSERM U1093), it was demonstrated that the application of ES to the motor nerve at low intensities did not induce discomfort in healthy subjects, but could induce substantial strength gains (+25%) with adaptations occurring at both in the muscles and the nerves. The proposed study is an innovative, randomized, pilot study based on motor nerve ES in a highly selected population of ICU patients in septic shock and therefore with a high risk of developing neuromyopathy, which is responsible for a significant increase in morbidity and mortality.